A Non-Interventional Study To Assess Sweating: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Non-Interventional Study To Assess Sweating (NCT02552199), a registered phase not stated study. The primary outcome is Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers)..

2. Clinical Question

The stated purpose was to evaluate gravimetric sweat measurements in people meeting subjective criteria for palmar hyperhidrosis and compare them with measurements in people without hyperhidrosis. Both palms were assessed in a temperature-controlled room. Assessments took place on two separate occasions over a five-minute period, with two assessments per palm.

This is a measurement-focused comparison between groups, not a test of a treatment. The registry record does not report numerical group means, standard deviations, or a statistical test of the group difference. It therefore does not establish the size or precision of any observed difference. The record also does not report how subjective diagnostic criteria were applied or how healthy volunteers were selected.

3. Trial Design

The study is identified as non-interventional and is marked completed. The registry record lists 28 participants as enrolled, with 17 in the group with hyperhidrosis and 11 in the healthy group. The study start is recorded as 2015-09 and primary completion as 2015-10. The sponsor is Botanix Pharmaceuticals.

The two groups are defined by participant status: patients with primary palmar hyperhidrosis and healthy adult patients or volunteers. Gravimetry is listed as the study intervention type, but in this context it is a measurement procedure rather than a treatment. The record describes collection of gauze weights before and after palmar contact, followed by calculation of palm-specific and total measurements.

The primary outcome is a continuous measure, total palmar gravimetric sweat production in grams, summarized as a mean and standard deviation and compared between subject groups. The described full analysis set includes all enrolled subjects. However, the registry record does not report participant flow, exclusions from analysis, actual numbers contributing outcome data, or numerical outcome summaries.

Allocation is not stated, and the record flags that this is not a randomized comparison. The two groups therefore represent different participant populations, not interchangeable arms established by random assignment. Any group difference could reflect differences related to hyperhidrosis, but also other differences between the groups or measurement conditions. Details of recruitment, matching, blinding, and control of potential confounding are not reported in the registry record.

The record lists one outcome measure and no analyses. It does not report a protocol-based sample-size justification, an interim analysis plan, or the statistical plan used for a formal comparison. The posted information supports describing the intended measurement and comparison, but not reconstructing the full conduct or analysis of the study.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Full analysis set including all enrolled subjects.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers)., measured over Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms..

The primary endpoint is mean average total palmar gravimetric sweat production, expressed in grams, compared between adults with hyperhidrosis and healthy adult volunteers. Gravimetry estimates sweat production by weighing gauze before and after contact with the palm. The palm-specific measurement is based on the change in gauze weight after five minutes of contact.

The record describes measurements of both palms at two separate occasions. It defines a total for each occasion by adding the right- and left-palm measurements, then describes comparing mean average total measurements between the subject groups. The reported summary measure is the mean, with standard deviation as the measure of dispersion.

As a continuous outcome, the measure can retain information about the magnitude of sweat production rather than classifying participants only as above or below a threshold. A group mean describes the average measurement, while the standard deviation describes how spread out measurements are around that average. These are general statistical interpretations; the registry record does not report the actual group means or standard deviations.

The endpoint is relevant to the stated measurement question because it quantifies palmar sweat production under a specified procedure. Its interpretation depends on consistent measurement conditions and on how repeated occasion-level observations are combined. The record describes the measurement procedure but does not report reliability estimates, measurement error, or numerical endpoint results. Consequently, it is not possible from the registry record to assess the magnitude, precision, or practical importance of a group difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome is continuous because it records an amount of sweat in grams rather than assigning each participant to a category. The registry record describes summarizing the endpoint with a mean and standard deviation. These statistics answer different questions: the mean indicates the average measurement, while the standard deviation describes the spread of individual measurements around that average. Neither statistic, by itself, expresses uncertainty in the estimated group difference.

What does gravimetry measure?

In general, gravimetry estimates the amount of material collected by comparing a weight before and after collection. In this study, gauze was weighed before palmar contact and again after five minutes of contact. The change in weight was used as the individual palm gravimetric sweat production. The record says assessments were conducted in a temperature-controlled room and that both palms were assessed on two separate occasions.

The described total for an occasion combines the right- and left-palm measurements. The primary comparison uses mean average total measurements between the group with hyperhidrosis and the healthy group. Repeated measurements can provide information about variation across occasions, but they also introduce an analysis consideration: measurements from the same participant are generally related rather than independent. In general, analyses of repeated measurements should reflect that dependence. The registry record does not report a model or other statistical procedure for doing so.

What does the standard deviation tell the reader?

In general, a standard deviation describes the dispersion of observations within a group. A larger spread means that measurements are more variable around the group mean; a smaller spread means they are more closely clustered. The standard deviation is not the same as a confidence interval. A confidence interval describes uncertainty in an estimated quantity, such as a mean or difference, under specified statistical assumptions. The registry record names standard deviation as the dispersion measure but provides no numerical values or confidence intervals.

Why does the comparison design matter?

The groups are defined by hyperhidrosis status, and random allocation is not stated. In general, randomization is used in treatment trials to reduce systematic differences between groups at baseline. A non-randomized group comparison cannot rely on that protection. Characteristics that differ between people with hyperhidrosis and healthy volunteers could also be related to sweat measurements. Adjusted analyses may address recorded covariates, but cannot necessarily remove unmeasured differences. The registry record does not report covariate adjustment, matching, or other methods to address confounding.

For a two-group continuous-outcome analysis, a useful estimate would ordinarily include a group contrast and an uncertainty measure, alongside descriptive summaries. The estimate would indicate the direction and magnitude of the observed contrast; its confidence interval would show the range of values compatible with the data under the analysis assumptions. A p-value, if used, would address compatibility with a null model, not the size or importance of an effect. These are general concepts. No such numerical results are reported in the registry record, and no specific inferential method can be identified from the posted information.

What is over-dispersion, and is it relevant?

Over-dispersion is a general concern when the observed variability in data is greater than a statistical model expects. It is particularly relevant to count outcomes modeled with distributions that assume a specific relationship between the mean and variance. This endpoint is described as a continuous measure summarized by a mean and standard deviation, so the registry record does not identify a count model or an over-dispersion adjustment. The general concept should not be mistaken for a reported feature of this analysis.

How should planning illustrations be read?

In general, a sample-size calculation estimates how many participants may be needed for a proposed design, given assumptions about the effect to detect, variability, significance level, allocation, and analysis. The record describes planning illustrations using a two-sided significance level of 0.05, equal allocation, a normal approximation, and fractions of an observed effect. Those illustrations are not the study's original design justification and are not observed power. They cannot substitute for reported outcome estimates. The registry record does not report the protocol's sample-size rationale, and no numerical planning results are stated in the registry record.

Overall, the recorded methods identify the measurement, summaries, and comparison groups, but they do not specify enough statistical detail to reproduce or evaluate a formal inferential analysis. In particular, the absence of numerical results and an analysis description prevents assessment of uncertainty, model fit, or the handling of repeated observations.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("With Hyperhidrosis", "Healthy")
n   <- c(17, 11)
m   <- c(0.7687, 0.1762)
sp  <- c(0.83, 0.101)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  With Hyperhidrosis  17  0.769  0.830  0.342  1.195
CARM  Healthy  11  0.176  0.101  0.108  0.244

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure. It does not report a multiplicity-control procedure or describe a broader family of primary hypotheses. When several outcomes or repeated inferential tests are examined, the chance of at least one apparently unusual result can increase; this is the general reason researchers may plan methods to control multiplicity. The posted information does not establish whether additional analyses were conducted outside the registry record.

The registry describes the full analysis set as including all enrolled subjects. It does not report how many participants contributed usable endpoint data, whether any participants were excluded from an analysis, or whether any measurements were missing. It also does not state how missing measurements were handled. The absence of a missing-data description should not be interpreted as proof that no data were missing.

Repeated measurements were collected from both palms on two separate occasions, and the record describes occasion-level totals and an average endpoint. It does not state what was done if an occasion or palm measurement was unavailable, nor does it describe a method for accounting for within-participant correlation. These details matter because the endpoint's precision and the validity of an inferential comparison can depend on how repeated observations are handled.

The record lists zero analyses and supplies no numerical outcome results. It does not report an analysis population beyond the description of the full analysis set, nor does it describe deviations from a planned analysis. The protocol's statistical analysis plan, interim analysis procedures, and any prespecified approach to multiplicity or missing data are not reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry record lists zero serious adverse events and zero other adverse events in the group with hyperhidrosis, which had 17 participants at risk. It lists zero serious adverse events and zero other adverse events in the healthy group, which had 11 participants at risk. Deaths are listed as zero in both groups.

These figures are counts recorded in the registry, not estimates of comparative safety. A zero count means that no events of the listed type are recorded for the group in this entry. It does not prove that an event could not occur, establish that monitoring captured every event, or demonstrate equivalence between groups. The group sizes and the non-randomized design also limit what can be inferred from a simple count comparison.

The study is non-interventional and focuses on gravimetric assessment rather than a treatment comparison. The registry record does not report event definitions, observation duration for safety, relatedness assessments, or details of adverse-event collection. It also does not list serious adverse-event terms. Therefore, these figures should be read narrowly as the adverse-event counts recorded for the two groups, without attributing them to a treatment or drawing broader safety conclusions.

13. What the Result Does, and Does Not, Mean

The registry record establishes that a completed non-interventional study was designed to compare gravimetric palmar sweat measurements between adults with primary hyperhidrosis and healthy adults. It describes a measurement procedure involving gauze, both palms, and two separate occasions, and identifies mean average total sweat production in grams as the primary endpoint.

It does not report numerical results for that endpoint. There is no posted group mean, standard deviation, estimated contrast, confidence interval, or p-value. As a result, the record does not indicate the direction or magnitude of any difference, or how precisely an estimate was obtained. It cannot answer whether the groups had similar or different measurements based on the posted outcome data.

Even if a numerical group difference were available, the design would need to be considered when interpreting it. Participants were grouped by hyperhidrosis status rather than randomized, and allocation is not stated. In general, an observed difference in such a comparison may reflect the condition being studied, other group characteristics, or both. The registry record does not report methods for adjusting for potential confounding.

The endpoint is a direct measurement under the described procedure, but its interpretation also depends on measurement consistency and the handling of repeated observations. The record does not report reliability, measurement error, missingness, or an inferential model. Consequently, the statistical meaning and precision of a group contrast cannot be evaluated from the registry entry.

The record supports a description of the study question and methods, not a conclusion about the size or importance of the empirical result. The listed adverse-event counts are also limited to registry counts and do not establish broader safety. The study's completed status should not be confused with availability of analyzed results.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of a measurement comparison rather than a randomized treatment trial. It asks whether a quantitative measure differs between people characterized by a condition and healthy volunteers. That question requires attention to how the measure is collected, how repeated observations are combined, and what other differences between groups might explain an observed contrast.

The gravimetric procedure is described in practical terms: gauze weights before and after contact are used to estimate sweat production, and measurements from both palms contribute to an occasion-level total. The outcome is continuous and is summarized by a mean and standard deviation. This makes clear what kind of data were intended and what descriptive quantities would help readers understand central tendency and spread.

The record also illustrates why reporting numerical results matters. A completed status and a defined endpoint do not tell readers the observed group averages, their variability, or the uncertainty around a comparison. Without those results, the central statistical question remains unresolved in the registry record. A design description cannot replace an estimate and its precision.

Finally, the non-randomized structure is important. Comparing distinct participant groups can be useful for characterizing measurements, but it does not provide the same basis for causal interpretation as random assignment. Potential differences between groups need to be considered, and the registry entry does not report adjustment methods. The study therefore highlights both the value of specifying a measurement protocol and the limits created when analysis results and methodological details are not reported.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation of the registry entry is that it does not report numerical results for the primary endpoint. Although the outcome and comparison are described, the group means, standard deviations, estimated difference, uncertainty intervals, and inferential results are absent. The registry record lists zero analyses, so the magnitude and precision of the comparison cannot be assessed.

The study is non-interventional, and allocation is not stated. The groups are participants with hyperhidrosis and healthy adults, not randomized arms. Differences in participant characteristics could contribute to any measured contrast. The registry record does not report matching, covariate adjustment, or other strategies for addressing confounding, and it does not provide demographic details that would help assess group comparability.

The measurement description includes repeated occasion-level measurements and both palms, but the analysis method is not specified. The record does not say how within-participant dependence was handled or whether all intended measurements were available. It also does not report measurement reliability, missing-data handling, exclusions, or the actual number contributing outcome data.

Further details that could clarify interpretation, including recruitment procedures, diagnostic criteria, blinding, and protocol-based sample-size justification, are not reported in the registry record. The record describes planning illustrations, but they are not the study's own design rationale or evidence of observed power. The adverse-event entries also lack event-collection details and should be interpreted only as recorded counts. Together, these gaps restrict evaluation of both the outcome comparison and the study's conduct.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Non-Interventional Study To Assess Sweating — NCT02552199.
• Registry record last updated 2024-02-15; status last verified 2024-02.
• Results first posted 2023-10-23.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT02552199 is a completed, non-interventional study sponsored by Botanix Pharmaceuticals. It enrolled 28 participants and compared adults with primary palmar hyperhidrosis with healthy adults. The registry record lists gravimetry as the measurement procedure and identifies mean average total palmar gravimetric sweat production, in grams, as the primary outcome.

Measurements were conducted in a temperature-controlled room on two separate occasions over a five-minute period, with both palms assessed. The record describes a full analysis set including all enrolled subjects, but lists zero analyses and does not report numerical outcome results. Group counts were 17 participants with hyperhidrosis and 11 healthy participants. Serious and other adverse-event counts, as well as deaths, are recorded as zero in both groups.

The registry entry defines the measurement question but does not establish the size, direction, or precision of a group difference. Allocation is not stated, and the comparison is not randomized.